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BIOMARKER:

Chr t(11;14)

10d
CORONADO CLL: RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia (clinicaltrials.gov)
P1/2, N=5, Terminated, University of Utah | N=39 --> 5 | Trial completion date: Aug 2027 --> Oct 2024 | Recruiting --> Terminated; This study was terminated due to sponsor de-activation of all programs associated with RP-3500 (camonsertib).
Enrollment change • Trial completion date • Trial termination
|
TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • SF3B1 (Splicing Factor 3b Subunit 1) • CCND1 (Cyclin D1) • CD5 (CD5 Molecule) • POT1 (Protection of telomeres 1) • FCER2 (Fc Fragment Of IgE Receptor II)
|
TP53 mutation • ATM mutation • Chr t(11;14) • SF3B1 mutation
|
Lynparza (olaparib) • camonsertib (RP-3500)
10d
Trial completion date • Trial primary completion date • Adverse events • Combination therapy
|
BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
|
Chr t(11;14) • CCND1 overexpression
|
Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • prednisone • Jaypirca (pirtobrutinib) • Epkinly (epcoritamab-bysp) • Polivy (polatuzumab vedotin-piiq) • golcadomide (CC-99282)
18d
Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission (clinicaltrials.gov)
P3, N=689, Active, not recruiting, ECOG-ACRIN Cancer Research Group | Recruiting --> Active, not recruiting | Trial completion date: Jan 2032 --> Jan 2027
Enrollment closed • Trial completion date
|
CCND1 (Cyclin D1) • CD4 (CD4 Molecule) • SOX11 (SRY-Box Transcription Factor 11)
|
Chr t(11;14) • SOX11 expression
|
clonoSEQ
|
Truxima (rituximab-abbs) • Rituxan Hycela (rituximab/hyaluronidase) • Mabtas (rituximab biosimilar)
23d
Robust anti-myeloma effect of TAS0612, an RSK/AKT/S6K inhibitor, with venetoclax regardless of cytogenetic abnormalities. (PubMed, Leukemia)
Moreover, the combination of TAS0612 with venetoclax (VEN) showed the synergy in inducing apoptosis in HMCLs irrespective of the t(11;14) translocation status. TAS0612 alone and combined with VEN are new potent candidate therapeutic strategies for MM, regardless of cytogenetic/genetic profiles, facilitating its future clinical development.
Journal
|
RPS6KA3 (Ribosomal Protein S6 Kinase A3) • PDPK1 (3-Phosphoinositide dependent protein kinase 1)
|
Chr t(11;14)
|
Venclexta (venetoclax) • TAS0612
24d
A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets (clinicaltrials.gov)
P1, N=34, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting | N=360 --> 34 | Trial completion date: Aug 2026 --> Dec 2025 | Trial primary completion date: Aug 2026 --> Feb 2024
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Adverse events • IO biomarker
|
BCL2 (B-cell CLL/lymphoma 2)
|
Chr t(11;14)
|
lenalidomide • Darzalex (daratumumab) • dexamethasone • ABBV-453
26d
MRD Detection in B-Cell Non-Hodgkin Lymphomas Using Ig Gene Rearrangements and Chromosomal Translocations as Targets for Real-Time Quantitative PCR and ddPCR. (PubMed, Methods Mol Biol)
However, it should be noted that MRD diagnostics for clinical treatment protocols has to be accompanied by regular international quality control rounds to ensure the reproducibility and reliability of the MRD results. This is available by the EuroMRD network ( https://euromrd.org ), a subgroup of ESHLO ( https://eslho.org ).
Journal • IO biomarker
|
BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • IGH (Immunoglobulin Heavy Locus)
|
Chr t(11;14) • Chr t(11;14)(q13;q32) • BCL2 fusion
29d
A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL (clinicaltrials.gov)
P2, N=27, Completed, Dana-Farber Cancer Institute | Active, not recruiting --> Completed | N=50 --> 27
Trial completion • Enrollment change
|
CD19 (CD19 Molecule) • CCND1 (Cyclin D1) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
|
Chr t(11;14) • CCND1 overexpression
|
Zydelig (idelalisib) • Arzerra (ofatumumab)
1m
Functional variant rs9344 at 11q13.3 regulates CCND1 expression in multiple myeloma with t(11;14). (PubMed, Leukemia)
Overexpression of PAX5 resulted in increased CCND1 expression. These results support the importance of rs9344 G enhancer in increasing CCND1 expression in MM.
Journal
|
CCND1 (Cyclin D1) • PAX5 (Paired Box 5)
|
Chr t(11;14) • CCND1 overexpression • CCND1 expression • Chr t(11;14)(q13;q32) • PAX5 overexpression • CCND1-H
2ms
NCI-2018-00315: Pevonedistat and Ibrutinib in Treating Participants With Relapsed or Refractory CLL or Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=18, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Dec 2024
Trial completion date • Trial primary completion date
|
CCND1 (Cyclin D1) • FCER2 (Fc Fragment Of IgE Receptor II)
|
Chr t(11;14) • CCND1 overexpression
|
Imbruvica (ibrutinib) • pevonedistat (MLN4924)
2ms
A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL (clinicaltrials.gov)
P2, N=29, Active, not recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Oct 2028 --> Oct 2034
Trial completion date
|
CD20 (Membrane Spanning 4-Domains A1) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
|
Chr t(11;14) • CD20 expression • CD19 expression
|
Imbruvica (ibrutinib) • fludarabine IV
2ms
ZN-d5-003: Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis (clinicaltrials.gov)
P1/2, N=18, Completed, K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. | Active, not recruiting --> Completed | N=135 --> 18 | Trial completion date: Dec 2025 --> Feb 2024 | Trial primary completion date: May 2025 --> Feb 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
|
Chr t(11;14)
|
ZN-d5
2ms
Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=3, Terminated, Academic and Community Cancer Research United | N=63 --> 3 | Trial completion date: Apr 2029 --> Mar 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Apr 2027 --> Mar 2024; Trial closed due to low accrual rate
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
|
CCND1 (Cyclin D1)
|
Chr t(11;14)
|
Venclexta (venetoclax) • Truxima (rituximab-abbs) • Rituxan Hycela (rituximab/hyaluronidase) • Polivy (polatuzumab vedotin-piiq)
2ms
Enrollment change • Trial completion date • Trial primary completion date • Adverse events • Combination therapy
|
BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
|
Chr t(11;14) • CCND1 overexpression
|
Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • prednisone • Jaypirca (pirtobrutinib) • Epkinly (epcoritamab-bysp) • Polivy (polatuzumab vedotin-piiq) • golcadomide (CC-99282)
2ms
Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=9, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=30 --> 9
Enrollment closed • Enrollment change
|
CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1)
|
CD20 positive • Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
|
Imbruvica (ibrutinib) • Calquence (acalabrutinib)
2ms
Precision medicine for multiple myeloma: The case for translocation (11;14). (PubMed, Cancer Treat Rev)
However, its distinct reliance on Bcl-2 has heightened its sensitivity to venetoclax. Further subclassification based on morphological and genomic characteristics could enhance our prediction models of treatment responses and enable more tailored therapeutic strategies for patients. This review aims to encapsulate the existing research evidence in this area.
Review • Journal
|
BCL2 (B-cell CLL/lymphoma 2)
|
Chr t(11;14)
|
Venclexta (venetoclax)
6ms
Cholecalciferol in Improving Survival in Patients With Newly Diagnosed Cancer With Vitamin D Insufficiency (clinicaltrials.gov)
P=N/A, N=500, Recruiting, Mayo Clinic | Trial completion date: Sep 2024 --> Mar 2025 | Trial primary completion date: Sep 2024 --> Mar 2025
Trial completion date • Trial primary completion date
|
CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II) • VDR (Vitamin D Receptor)
|
Chr t(11;14)
6ms
Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=39, Active, not recruiting, Alliance Foundation Trials, LLC. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date • Combination therapy
|
CCND1 (Cyclin D1) • CD4 (CD4 Molecule) • CD5 (CD5 Molecule)
|
Chr t(11;14)
|
Ibrance (palbociclib) • Imbruvica (ibrutinib)
7ms
Clonal Hematopoiesis of Indeterminate Potential in Patients with Immunoglobulin Light Chain AL Amyloidosis. (PubMed, Blood Adv)
At a median follow-up of 32.5 months, the presence of CHIP was not associated with worse overall survival or major organ dysfunction progression-free survival. Larger studies and longer follow-up are needed to better define the impact of CHIP in patients with AL amyloidosis.
Journal
|
DNMT3A (DNA methyltransferase 1)
|
DNMT3A mutation • Chr t(11;14)
7ms
Mantle Cell Lymphoma Under the Scope of Personalized Medicine: Perspective and Directions. (PubMed, Clin Lymphoma Myeloma Leuk)
This review synthesizes current knowledge on genetic mutations in MCL and their impact on prognosis. It aims to explore the prognostic value of genetic markers related to population traits, emphasizing the importance of tailored molecular medicine in MCL.
Review • Journal
|
TP53 (Tumor protein P53) • NOTCH1 (Notch 1) • CCND1 (Cyclin D1) • CCND2 (Cyclin D2) • SOX11 (SRY-Box Transcription Factor 11)
|
TP53 mutation • ATM mutation • Chr t(11;14) • CCND1 overexpression • CCND2 overexpression
7ms
Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=32, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=50 --> 32
Enrollment closed • Enrollment change
|
CCND1 (Cyclin D1)
|
Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
|
Venclexta (venetoclax) • Calquence (acalabrutinib)
7ms
Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM) (clinicaltrials.gov)
P2, N=120, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting | Trial completion date: Dec 2027 --> Jun 2027 | Trial primary completion date: Dec 2027 --> Jun 2027
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
|
Chr t(11;14)
|
Venclexta (venetoclax) • carfilzomib • dexamethasone
7ms
Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=15, Completed, SCRI Development Innovations, LLC | Active, not recruiting --> Completed | Trial completion date: Aug 2027 --> Apr 2024 | Trial primary completion date: Aug 2027 --> Apr 2024
Trial completion • Trial completion date • Trial primary completion date
|
CCND1 (Cyclin D1)
|
Chr t(11;14) • CCND1 expression
|
Calquence (acalabrutinib)
8ms
Steroid-free combination of 5-azacytidine and venetoclax for the treatment of multiple myeloma. (PubMed, Haematologica)
Lastly, we show for the first time in primary MM patient samples, that 5-azacytidine enhances the response to venetoclax ex-vivo, across diverse anti-apoptotic dependencies (BCL-2 or MCL-1) and diverse cytogenetic backgrounds. Overall, our data identifies 5-azacytidine and venetoclax as an effective treatment combination and this could be a tolerable steroid-sparing regimen, particularly for elderly MM patients.
Journal • IO biomarker
|
BCL2 (B-cell CLL/lymphoma 2) • MCL1 (Myeloid cell leukemia 1) • PMAIP1 (Phorbol-12-Myristate-13-Acetate-Induced Protein 1)
|
Chr t(11;14) • BCL2 overexpression
|
Venclexta (venetoclax) • azacitidine
8ms
Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=23, Active, not recruiting, Emory University | Trial primary completion date: Sep 2023 --> Sep 2024
Trial primary completion date
|
CCND1 (Cyclin D1)
|
Chr t(11;14)
|
Venclexta (venetoclax) • Gazyva (obinutuzumab) • bendamustine
8ms
CAPITAL: Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
P2, N=30, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2024 --> Jun 2024
Trial completion date
|
CCND1 (Cyclin D1)
|
Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
|
Truqap (capivasertib)
8ms
Allogenic CD19-targeting CAR-γδT Cell Therapy in r/r NHL (clinicaltrials.gov)
P1/2, N=30, Recruiting, Chinese PLA General Hospital | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • Chr t(11;14) • CCND1 overexpression • BCL6 rearrangement • Chr t(11;14)(q13;q32) • BCL2 rearrangement • CD20 negative
|
cyclophosphamide • fludarabine IV
8ms
Enrollment open • Combination therapy
|
Chr t(11;14)
|
Venclexta (venetoclax) • lenalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Hemady (dexamethasone tablets)
8ms
Trial completion • Combination therapy
|
BCL2 (B-cell CLL/lymphoma 2)
|
Chr t(11;14)
|
Venclexta (venetoclax) • Ninlaro (ixazomib)
9ms
Trial completion date
|
BCL2 (B-cell CLL/lymphoma 2)
|
Chr t(11;14)
|
Venclexta (venetoclax) • Actemra IV (tocilizumab)
9ms
Trial completion date
|
CD20 (Membrane Spanning 4-Domains A1) • CD4 (CD4 Molecule) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
|
Chr t(11;14)
|
Imbruvica (ibrutinib) • Rituxan (rituximab) • bendamustine • Belrapzo (bendamustine RTD) • Mabtas (rituximab biosimilar)
9ms
Twenty Years of Advancing Discoveries and Treatment of Mantle Cell Lymphoma. (PubMed, Oncology (Williston Park))
At the Lymphoma Research Foundation's 20th MCL Scientific Consortium and Workshop, researchers gathered to discuss recent developments in both basic scientific and clinical research to continue to develop an understanding of MCL and improve outcomes for patients. This report, which includes a summary of each presentation, reviews the findings presented at the workshop and highlights opportunities, open questions, and areas for future study that would pave the way for a cure for this disease in the coming decades.
Journal
|
CCND1 (Cyclin D1)
|
Chr t(11;14) • CCND1 overexpression
9ms
Decitabine-primed Tandem CD19/CD20 CAR T Cells Treatment in r/r B-NHL (clinicaltrials.gov)
P1/2, N=33, Recruiting, Han weidong | Trial primary completion date: Dec 2023 --> Dec 2024
Trial primary completion date • CAR T-Cell Therapy
|
BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
|
Chr t(11;14) • CCND1 overexpression • BCL6 rearrangement • Chr t(11;14)(q13;q32) • BCL2 rearrangement • CD20 negative
|
cyclophosphamide • decitabine • fludarabine IV
9ms
Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
P2, N=15, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
Trial completion date • Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • FCER2 (Fc Fragment Of IgE Receptor II)
|
Chr t(11;14) • CCND1 overexpression
|
Copiktra (duvelisib) • ETP-47187
9ms
Trial completion date • Combination therapy
|
CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • PAX5 (Paired Box 5) • CD5 (CD5 Molecule)
|
Chr t(11;14) • CCND1 expression
|
Imbruvica (ibrutinib) • Rituxan (rituximab) • bendamustine
9ms
Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma (clinicaltrials.gov)
P1, N=28, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jan 2025
Trial completion date
|
CCND1 (Cyclin D1) • CD5 (CD5 Molecule)
|
Chr t(11;14)
|
Ibrance (palbociclib) • Imbruvica (ibrutinib)
9ms
Enrollment open
|
TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • SF3B1 (Splicing Factor 3b Subunit 1) • CCND1 (Cyclin D1) • CD5 (CD5 Molecule) • POT1 (Protection of telomeres 1) • FCER2 (Fc Fragment Of IgE Receptor II)
|
TP53 mutation • ATM mutation • Chr t(11;14) • SF3B1 mutation
|
Lynparza (olaparib) • camonsertib (RP-3500)
9ms
ALTAMIRA: Acalabrutinib and Rituximab in Elderly Patients With Untreated Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=81, Active, not recruiting, Nordic Lymphoma Group | Recruiting --> Active, not recruiting
Enrollment closed
|
CCND1 (Cyclin D1)
|
Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
|
Rituxan (rituximab) • Calquence (acalabrutinib)
9ms
Enrollment closed
|
Chr t(11;14)
|
Venclexta (venetoclax) • dexamethasone • pomalidomide
9ms
Trial completion
|
CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • IGH (Immunoglobulin Heavy Locus) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
|
Chr t(11;14) • CD20 expression
|
cytarabine • doxorubicin hydrochloride • cyclophosphamide • vincristine • Arzerra (ofatumumab) • Starasid (cytarabine ocfosfate) • dexamethasone injection • methotrexate IV
10ms
A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets (clinicaltrials.gov)
P1, N=360, Recruiting, AbbVie | Trial completion date: Apr 2026 --> Aug 2026 | Trial primary completion date: Apr 2026 --> Aug 2026
Trial completion date • Trial primary completion date • Adverse events • IO biomarker
|
BCL2 (B-cell CLL/lymphoma 2)
|
Chr t(11;14)
|
lenalidomide • Darzalex (daratumumab) • dexamethasone • ABBV-453
10ms
A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P2, N=39, Not yet recruiting, Oncotherapeutics | Initiation date: Dec 2023 --> Mar 2024
Trial initiation date • Combination therapy
|
BCL2 (B-cell CLL/lymphoma 2) • TNFA (Tumor Necrosis Factor-Alpha)
|
Chr t(11;14)
|
Venclexta (venetoclax) • carfilzomib • Sarclisa (isatuximab-irfc) • dexamethasone injection
10ms
ACE-LY-004: An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=124, Active, not recruiting, Acerta Pharma BV | Trial completion date: Dec 2025 --> Sep 2026
Trial completion date
|
CCND1 (Cyclin D1)
|
Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
|
Calquence (acalabrutinib)